Table 2 Summary of phase III clinical trials evaluating the efficacy of ASCT in the era of novel agent induction therapy
Clinical trial | No. | Induction | Randomized arms | ORR | EFS/PFS | OS |
|---|---|---|---|---|---|---|
Palumbo et al. [20]. NDMM pts <65 y/o | 402 | Rd × 4 cycles | MPR × 6 cycles →No maint | CR (post consolidation): 18% | Median PFS: 22 mos | 5-year OS: 59% |
MPR × 6 cycles →R-maint |  | Median PFS: 34 mos | 5-year OS: 70% | |||
Mel200 mg/m2 × 2 cycles → No maint | CR (post consolidation): 23% | Median PFS: 37 mos | 5-year OS: 67% | |||
Mel200 mg/m2 × 2 cycles → R-maint |  | Median PFS: 55 mos | 5-year OS: 78% | |||
Gay et al. [21]. NDMM pts ≤65 y/o | 389 | Rd × 4 cycles | CRd × 6 cycles → R-maint | CR: 27% | Median PFS: 28 mos | 4-year OS: 76% |
CRd × 6 cycles → Rp-maint | CR: 23% | Median PFS: 24 mos | 4-year OS: 68% | |||
Mel200 mg/m2 × 2 cycles → R-maint | CR: 33% | Median PFS: 32 mos | 4-year OS: 75% | |||
Mel200 mg/m2 × 2 cycles → Rp-maint | CR: 37% | Median PFS: 38 mos | 4-year OS: 77% | |||
Cavo et al. [23]. NDMM pts ≤65 y/o | 1503 | VCd × 3–4 cycles | VMP→+/− VRd → R-maint | ≥VGPR: 75% | 3-year PFS: 57% | Median OS: NR |
Mel200 mg/m2 × 1 or 2 →+/− VRd →R-maint | ≥VGPR: 84% | 3-year PFS: 64% | Median OS: NR | |||
Attal et al. [25]. NDMM pts ≤65 y/o | 700 | VRd × 3 cycles | VRd × 5 cycles →R-maint | CR: 48% MRD (−): 65% | Median PFS: 36 mos | 4-year OS: 82% |
Mel200 mg/m2 →VRd × 2 cycles →R-maint | CR: 59% MRD (−): 79% | Median PFS: 50 mos | 4-year OS: 81% |